Lonza · 9 hours ago
QA Specialist II-Lot Release
Portsmouth, NH
Full-time
Onsite
Mid Level
$62K/yr - $98K/yrLonza is a global leader in life sciences manufacturing, and they are seeking a QA Specialist II - Lot Release to ensure the timely and compliant release of production batches. The role involves independent review of batch documentation, coordination with cross-functional teams, and mentorship of junior QA staff.
BiotechnologyLife SciencePharmaceutical
Responsibilities
Independently review and close batch disposition checklists and all supporting documentation required for production batch release
Collect, compile, and review executed batch documentation in accordance with approved procedures, product specifications, and batch disposition checklists
Review executed batch records, QC release assays, controlled testing (internal and contracted), and customer-controlled testing to ensure compliance with specifications
Prepare and compile complete batch release packages, including Certificates of Analysis (CoA) and final product labels
Create, revise, and maintain product specifications, act as document owner for specification changes as applicable
Facilitate daily batch release meetings with cross-functional stakeholders using visual management systems; maintain site-wide batch release schedules and metrics
Interact with Manufacturing, Quality Control, Supply Chain, and other stakeholders to obtain batch release deliverables in a timely manner
Complete SAP movements and support daily management systems
Support final product shipment activities, including labeling, shipping documentation, and transmission of batch documentation to customers per Quality Agreements
Maintain the site GMP label system, including master label books, label creation, user access control, and quarterly audits of label software users
Identify, assess, and investigate nonconformances (simple and complex), understand GMP implications, and determine appropriate actions with minimal management guidance
Apply Data Integrity principles in all aspects of work in compliance with company policies and procedures
Train, coach, and mentor junior QA Specialists; guide release priorities and support decision-making
Lead or participate in process improvement initiatives and cross-functional projects
Interact with regulatory inspectors, customer auditors, and internal auditors as a batch release subject matter expert
Perform other duties as assigned
Qualification
Required
Demonstrated hands-on experience in Quality Assurance within a regulated manufacturing environment, with direct involvement in batch record review, product disposition, and GMP-compliant documentation. A combination of education and years of experience will be considered
Proficiency with Microsoft Office tools (Word, Excel, Outlook); experience with SAP and TrackWise preferred
Working knowledge of cGMP regulations and guidelines (e.g., ICH Q7, 21 CFR Parts 210/211, 820)
Strong attention to detail, critical thinking, and problem-solving skills
Demonstrated ability to identify nonconformances, assess risk, and escalate issues appropriately with or without guidance
Motivated self-starter with the ability to adapt to changing priorities and manage multiple deliverables
Ability to work effectively both independently and within a team environment
Clear and logical communication skills with the ability to present facts, understand differing perspectives, and collaborate across functions
Preferred
Experience with SAP and TrackWise
Experience supporting batch release, product disposition, labeling systems, and regulatory or customer audits
Benefits
Performance-related bonus.
Medical, dental and vision insurance.
401(k) matching plan.
Life insurance, as well as short-term and long-term disability insurance.
Employee assistance programs.
Paid time off (PTO).
Company
Lonza
Lonza Group supplies products and services to pharmaceutical and agrochemical industries.
Founded in 1897
10001+ employees
H1B Sponsorship
Lonza has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2022 (1)
2021 (3)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$444.8M2023-11-06Post Ipo Debt· $444.8M
2020-12-07IPO
Leadership Team
Wolfgang Wienand
Chief Executive Officer
Alfons Ehinger
Founder
Recent News
NH Business Review
2026-01-17
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